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Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE

NCT02444728 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-03-14

No results posted yet for this study

Summary

Treating severe thrombocytopenia is a challenge in the management of systemic lupus erythematosus. Although rheumatologists have followed some rules in real practice,there is very few evidence to support the current treatment algorithm. The purpose of this study is to compare the complete remission rate and partial remission rate of cyclophosphamide and hydroxychloroquine for treating severe thrombocytopenia in Chinese SLE patients.

Conditions

Interventions

DRUG

Hydroxychloroquine

Hydroxychloroquine 200 mg BID for 12 months

DRUG

Cyclophosphamide

Cyclophosphamide 1000mg intravenous infusion every month for 6 months

DRUG

Azathioprine

After Cyclophosphamide treatment, Azathioprine 100mg once daily for 6 months

DRUG

Methylprednisolone

Methylprednisolone 40-50 mg once daily for 1 months and then taped for 12 months

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Chinese SLE Treatment And Research Group

    lead OTHER

Principal Investigators

  • Xiaofeng Zeng, MD · Chinese SLE Treatment And Research Group

  • Xiaofeng Zeng, MD · Peking Union Medical College Hospital

  • Xinping Tian, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-12-30
Completion
2018-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02444728 on ClinicalTrials.gov